BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1852847 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14801
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUTS. IT WAS ALSO NOTED THAT THE HISTORICAL DAILY MEASUREMENTS STORED BY THE DEVICE SHOWED RISING IMPEDANCE MEASUREMENTS AND DECLINING R-WAVE AMPLITUDE MEASUREMENTS. THE PHYSICIAN STATED THAT HE BELIEVES THAT THE RV LEAD PERFORMANCE ISSUE COULD HAVE BEEN CAUSED BY A DIALYSIS CATHETER THAT WAS INSERTED VIA LEFT SIDE ACCESS. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 4076| 1290| 4088| S404| 4136